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510(k) Data Aggregation

    K Number
    K080605
    Device Name
    SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
    Manufacturer
    CURBELL ELECTRONICS INC.
    Date Cleared
    2008-05-05

    (62 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K884592
    Why did this record match?
    Device Name :

    SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sure-Lock electrode clips provide a connection between lead wires and ECG/EKG electrodes (button & tab style).

    Device Description

    ECG/EKG electrode clip

    AI/ML Overview

    This document describes a Special 510(k) submission for a Sure-Lock electrode clip, focusing on changes to the device rather than a new AI/ML device. Therefore, many of the requested elements for an AI/ML device (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable to this submission.

    The acceptance criteria and "study" proving the device meets them are related to the safety and effectiveness of the proposed changes compared to the predicate device, demonstrated through non-clinical performance data and adherence to recognized standards.

    Here's the breakdown of the information that is applicable:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Performance Standard)Reported Device Performance (Compliance)
    ANSI/AAMI EC53:1995Assessed to standard (Implied compliance)
    ANSI/AAMI EC53/A1:1998Assessed to standard (Implied compliance)
    Equivalence to predicate device K884592Achieved through nonclinical testing
    Insulation material change (polymethylpentene to polycarbonate)Verified through "Engineering Test Report: SURE-LOCK Material Comparison-Polymethylpentene and Makrolon 2458"
    DFU/label change (3mm-4mm safety banana plug)Verified through attached DFU/label update
    DFU/label change (Caution: cleaning)Verified through "Engineering Test Report: SURE-LOCK Connector Performance" and attached DFU/label update
    DFU/label change (Note: 10 sterilization cycles by ETO)Verified through "Engineering Test Report: ECG Cables and Leads Verification Testing" and attached DFU/label update
    DFU/label change (compatible electrodes table)Verified through "Engineering Test Report: SURE-LOCK Electrode Compatibility" and attached DFU/label update

    2. Sample size used for the test set and the data provenance

    • Not Applicable. This is a device modification submission, not an AI/ML study involving a test dataset for algorithm performance. The "test set" here refers to the actual physical devices undergoing engineering testing. Data provenance would be from internal engineering tests conducted by Curbell Electronics, Inc.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not Applicable. Ground truth in the context of an AI/ML study is not relevant here. The "ground truth" for this device modification is compliance with established performance standards and the predicate device's baseline performance. This would have been established by Curbell's internal engineering and quality personnel.

    4. Adjudication method for the test set

    • Not Applicable. No human adjudication of diagnostic output from an algorithm is involved. Device performance testing would follow standard engineering and quality control procedures.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not Applicable. This is not an AI/ML device, and no MRMC study was performed.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not Applicable. This is not an AI/ML device.

    7. The type of ground truth used

    • For the physical device modifications, the "ground truth" involves compliance with industry performance standards (ANSI/AAMI EC53:1995 and EC53/A1:1998) and comparison to the established performance of the legally marketed predicate device (K884592). Additionally, internal engineering test reports serve as evidence for the specific material, cleaning, sterilization, and electrode compatibility changes.

    8. The sample size for the training set

    • Not Applicable. This is not an AI/ML device.

    9. How the ground truth for the training set was established

    • Not Applicable. This is not an AI/ML device.
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